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Clinical Trials in the UK / NCT07301736
Recruiting Phase 2

Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma

NCT07301736 · tracked via the Priya Life Science UK tracker
Sponsor
Chiesi Farmaceutici S.p.A.
Phase
Phase 2
Started
2025-12-17
Last updated
2026-06-25

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

CHF5993 pMDI with HFA-152aCHF5993 pMDI with HFA-134aCHF718 pMDI with HFA-134a

CHF5993 pMDI with HFA-152a: two puffs BID (twice daily)

CHF5993 pMDI with HFA-134a: two puffs BID

CHF718 pMDI with HFA-134a: two puffs BID

Study summary

This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years; * Non-smokers, ex-smokers; * Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive; * Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with: 1. low or medium doses of ICS (Inhaled Corticosteroids) alone; or 2. low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination). * Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score \<1.5 at screening and at randomisation. * Pre-BD (Bronchodilator) FEV1 \>40% and \<90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1). * A demonstrated increase in either FEV1 or forced vital capacity of \>12% and \>200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1). Exclusion Criteria: * History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk; * Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period ; * Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine; * Asthma subjects currently treated with any of the following : 1. High dose ICS; 2. Long-acting muscarinic antagonist (LAMA); 3. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening; 4. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening; 5. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening; * Respiratory disorders other than asthma * Lung resection; * Lower respiratory tract infection; * Lung cancer and history of lung cancer; * Subjects with active cancer or a history of cancer (other than lungs) ; * Patients who have clinically significant cardiovascular condition; * Run-in compliance: e-Diary completion \<75% and run-in treatment compliance \<75% at randomisation;

Primary outcome measure(s)

Trial sites (167)

FacilityCityRegionStatus
Hospital Británico de Buenos Aires_Site n. 032029 Buenos Aires Argentina Recruiting
Centro Medico de Enfermedades Respiratorias_Site n. 032002 Buenos Aires Argentina Recruiting
Centro Medico Respire_Site n. 032014 Buenos Aires Argentina Recruiting
Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018 Buenos Aires Argentina Recruiting
Centro de Investigaciones Médicas Mar del Plata_Site n. 032019 Buenos Aires Argentina Recruiting
Fundacion CIDEA_Site n. 032009 Buenos Aires Argentina Recruiting
Centro Medico Arsema_Site n. 032003 Buenos Aires Argentina Recruiting
Centro de Investigaciones Metabólicas (CINME)_Site n. 032025 Ciudad Autonoma de Buenos Aire Argentina Recruiting
Centro de Medicina Respiratoria - Concepcion del Uruguay_Site n. 032015 Ciudad Autonoma de Buenos Aire Argentina Recruiting
CARE - Centro de Alergia y Enfermedades Respiratorias_Site n. 032028 Ciudad Autonoma de Buenos Aire Argentina Recruiting
Consultorio Medico Dra. Rivera_Site n. 032012 Ciudad Autonoma de Buenos Aire Argentina Recruiting
Fundación Respirar Salud_Site n. 032004 Ciudad Autonoma de Buenos Aire Argentina Recruiting
Instituto de Medicina Respiratoria (IMER) - Cordoba_Site n. 032023 Córdoba Argentina Recruiting
CePIR_Site n. 032021 La Plata Argentina Recruiting
Fundacion Scherbovsky_Site n. 032013 Mendoza Argentina Recruiting
Instituto Medico INSARES SA_Site n. 032005 Mendoza Argentina Recruiting
Cimro Consultorios Medicos - Centro de Investigacion_Site n. 032006 Mendoza Argentina Recruiting
Centro Respiratorio Quilmes_Site n. 032007 Quilmes Argentina Recruiting
Fundacion Innovaciencia_Site n. 032017 Rosario Argentina Recruiting
Instituto de Especialidades de la Salud Rosario_Site n. 032020 Rosario Argentina Recruiting
Instituto Medico de la Fundacion de Estudios Clínicos_Site n. 032001 Rosario Argentina Recruiting
Fundacion Grupo Colaborativo Rosario_Site n. 032010 Rosario Argentina Recruiting
Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM)_Site n. 032011 San Juan Bautista Argentina Recruiting
Centro Modelo de Cardiologia SRL_Site n. 032016 San Miguel de Tucumán Argentina Recruiting
Clinica Mayo de UMCB SRL_Site n. 032026 San Miguel de Tucumán Argentina Recruiting
Investigaciones en Patologias Respiratorias_Site n. 032022 San Miguel de Tucumán Argentina Recruiting
IBAMEDICA_Site n. 032008 Santa Fe Argentina Recruiting
University Clinical Centre of the Republic of Srpska - Paprikovac_Site n. 070004 Banja Luka Bosnia and Herzegovina Recruiting
Sveti apostol Luka Doboj_Site n. 070005 Doboj Bosnia and Herzegovina Recruiting
Dr. Abdulah Nakas General Hospital_Site n. 070007 Sarajevo Bosnia and Herzegovina Recruiting
Dr. Abdulah Nakas General Hospital_Site n. 070009 Sarajevo Bosnia and Herzegovina Recruiting
Organizational unit Novi Grad_Site n. 070003 Sarajevo Bosnia and Herzegovina Recruiting
University Clinical Hospital Mostar_Site n. 07001 Siroki Brijeg Bosnia and Herzegovina Recruiting
Opca Bolnica Tesanj_Site n. 070006 Tešanj Bosnia and Herzegovina Recruiting
Dr. Mustafa Sehovic Public Medical Center_Site n. 070008 Tuzla Bosnia and Herzegovina Recruiting
University Clinical Centre Tuzla_Site n. 070002 Tuzla Bosnia and Herzegovina Recruiting
MHAT Sv. Ivan Rilski - Gorna Oryahovitsa_Site n.100017 Gorna Oryahovitsa Bulgaria Recruiting
Medical Center Pulmo - 2018_Site n. 100007 Haskovo Bulgaria Recruiting
MC ZDRAVE 1 - Kozloduy_Site n. 100009 Kozloduy Bulgaria Recruiting
Medical Centre Pratia Clinic EOOD - Lovech_Site n. 100012 Lovech Bulgaria Recruiting

+ 127 more sites — see the full list on the official registry below.

More Chiesi Farmaceutici S.p.A. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07301736 on ClinicalTrials.gov ↗ ← All trials in the UK